This invention relates to a method, routines and system for identification of imprints on dosage forms, whether defined by the United States Pharmacoepia or not, thereby assisting in the identification of the drug product. In particular, the invention is directed towards dosage forms other than liquids, inhalants and parenterals.
In 1962, the article “Identification Guide for Solid Dosage Forms” by Hefferren et al. (Hefferren, J. J. et al., Identification Guide for Solid Dosage Forms, Journal of the American Medical Association, Dec. 22, 1962), hereinafter the “Guide,” described an attempt to identify tablets, capsules and softgels by their size, shape, color and markings for approximately 5000 drug products. The method used physical measurement of size, assignment of the unknown drug product to predetermined shapes, matching color to a standard color reference such as ‘paint chips’ and markings on dosage forms known within the industry as “imprint.” Only a few drug products bore an imprint at that time. The Guide was of particular benefit in emergency rooms and coroners' laboratories because of their need to know and their ability to physically manipulate unknown drug products. However, in the process of identification, the specimen of the drug product was destroyed in many cases. At each step of the decision-tree in the Guide, the user's choices were “narrowed to one or, at most, a relatively few drugs. A tentative identification was thus established.
At that time the state-of-the-art of tablet and capsule identification was primitive by today's standards. Experts, such as forensic scientists, pharmacists and specialists in poison centers could be relied upon to use the Guide, but it had little utility in non-expert hands. The Guide has not been formally maintained and no new products have been cataloged since June 1962.
An effective system to make any physical identification must rely on objective, rather than subjective, information or data points. Size is objective but its measurement is fraught with difficulties—standard tools and methods and their immediate availability are needed in expert hands. However, shape is subjective, as it is difficult at times to describe the overall appearance of a dosage form verbally. The description of a dosage form as oblong, oval or caplet does not provide a definitive description. Similarly, color is subjective. It is difficult to describe the color of a dosage form, as example, such as pink, coral, peach or rose verbally without the use of a color chip.
A survey of the available resources is instructive: no print resource nor existing electronic catalog was or is adequate to fully meet the technical demands of identifying a drug product, by professionals and the public at large. In the current art, both print and electronic resources exclude non-numeric, non-alphabetic information, which leads users to the situation of multiple choices from which to make an identification. Lastly, print resources are dated from the day they are published and rapidly decline in value.
An electronic catalog was copyrighted in 1974. Its methodology presented imprints in text-only format, e.g., 93 150 3 (93=Teva Labs and 150 3 distinguishes it as an acetaminophen 325 mg and codeine 30 mg tablet) even though logos were already a common feature of imprints. Unable to accommodate logos, this catalog increased the possibility of finding an imprint by listing all possible combinations of imprint features but redundancy reduced its ease of use. Burden of these combinations within the catalog soon becomes obvious to the user. Lacking any discriminating routine for attacking imprints, the user has 398 choices from which to make an identification if the feature 93 is used for the initial search, 140 choices if the feature 150 is chosen and 210 choices if the feature 3 is chosen, all of which choices may require the user to assess them individually in order to arrive at a possible identification. Users may also be impeded by the multiplicity of screens needing to be reviewed; as in the exemplary imprint 93 150 3 above, the electronic catalog presents nine or ten screens displaying the multiple records. In another example, the imprint BRA 200 may be identified approaching first the feature BRA then 200 but not by approaching feature 200 and then BRA. After examining a list of 359 possibilities containing the feature 200, the user finds that the feature BRA is absent. In another example, the imprint 230, the user must evaluate 16 records to make a rather simple identification. The electronic catalog presents a multiplicity of choices but makes no definitive declaration of identification for users.
Furthermore, because of the text-only format of the electronic catalog, direct representation of logo features is precluded. The catalog contrives, as an example, the Abbott Laboratories logo with either the capital letter A or E, while a lower-case printed letter ‘a’ might be a better expression, but still not a direct expression, of the logo itself. Other logos may not lend themselves to such contrivances, consequently expensing valuable information. The user may be left with no direct representation of logo imprint features and at times outright absence of information, all serious deficiencies for a leading reference in the field.
For the above reasons the electronic catalog cannot be definitive in making a positive identification. It follows then that a reasonable strategy for the publisher of the electronic catalog might be to limit its use to experts. In fact, each resultant informational screen bears the legend “All POISONDEX® product information is CONFIDENTIAL, intended for use by healthcare professionals, and may not be released to non-medical personnel.”
Lastly, this imprint catalog, initially and for more than a decade afterward, did not include the National Drug Code (NDC) in each record although NDCs were widely in use since the 1960s. Consequently, no search to confirm a drug product by its NDC is currently available. Regardless of its dated features and reflecting the burgeoning drug market, the current electronic catalog has had a market for its more than 30,000 imprints and their combinations, whether they exist or not on a current drug product, for nearly the past three decades.
Recently several websites offer direct searches of databases for imprints on tablets and capsules, specifically www.rxlist.com and identadrug.com. The former site is not easy to use, both lack a comprehensive database of imprints and neither accommodates logo imprint features. More significantly, the former site uses no more technology with which to search for an imprint than a simple ‘grep’—input of a string of characters or digits as seen in the imprint, but not logos, leading to the output of multiple records containing the same string somewhere therein and not necessarily related to the imprint itself. At both sites the user is left with making a choice; no definitive declaration of an identification is provided. Their technology is little different from that of the 1974 electronic catalog discussed above.
Yet another database marketed on a CD-ROM disc uses color, shape and scoring as input to its search routines. The routines are difficult to use and the database is incomplete. Again the user is left with choices from a multiplicity of records in order to make the identification. This database has been developed with no more technology than that used by the Guide reported by Hefferren in 1962. If the user misrepresents color, shape or scoring, likely no records will be found and no identification can be made.
A prior art compilation of records for automated database has been developed, containing drug product records of imprint features in text only and associated descriptors. This compilation has the title Readi-TCID©. However, Readi-TCID© does not have nor utilize method and routines for identifying definitively an imprint of dosage forms. The database only displays a collage of imprint logos as found on tablets and capsules in the United States known at the time of development.
U.S. Pat. No. 6,025,984 describes a portable drug information computer. However, the '984 patent is not capable of identifying imprints on dosage forms. Similarly, U.S. Pat. No. 4,289,958 generally relates to a device to take physical measurements and to compare these measurements and shapes to a data set punched into cards. The data set makes no reference to using an imprint as a means of making or confirming an identification of a dosage form. Both patents have the significant drawback that they deal with the least effective means of making an identification today—shape and scoring.
U.S. Pat. Nos. 5,700,998 and 5,845,264 both overlook the current US FDA required imprints on solid dosage forms in certain drug categories and further claim an indicia using bar code that may be applied to the surface of selected dosage forms. Further, pharmacies, hospitals, nursing homes and possibly consumers require specialized equipment to read the indicia whenever and wherever an identification is required for selected dosage forms. Bar code indicia applied to dosage forms is redundant to current practices, cannot be visualized at will by the unaided eye, is far more complex than drug makers' current imprinting methods and may have limited applicability in the case of some solid dosage forms.
All of the previously discussed methods and systems of drug identification have significant drawbacks, relying on technology in use for more than thirty years. It is an object of the present invention to solve these and other problems and to claim the development of new technology in the art of identifying tablets and capsules. The present invention alters no present regulation or production methods and its method and routines are applicable to the unaided eye, readily available computer technology and equipment and any applicable, comprehensive database. The present invention accommodates all dosage forms and all imprint features—both non-numeric and non-alphabetic as well as numeric digits and alphabetic characters—and organizes all imprint features with the goal of the least number of decisions within its routines to arrive at a declarative identification.
Identification of drug products is made by using the common descriptors of the art and associating them with imprint features within an applicable database. First the process involves a method of assigning all, including heretofore unrecognized or unused, imprint features as components within classes in a database. Secondly, routines permit users of the system to compare imprint features, as seen on dosage forms, to database components, presented in a hierarchy of classes and aided by computer programs.
Novel method and routines of the present invention avoid the problems of matching dosage form physical characteristics, of using only partial catalogs or data sets, all of which are significantly devoid of logos and of lacking the cardinal concept: imprints are unique. By method herein, the features of imprints are the sole independent variables and physical characteristics are solely descriptors and dependent variables. The method, routines and system of the present invention are elegant in their simplicity and solve longstanding and intractable problems in the art.